Access to Hormonal Contraception: Is It Time We Considered Over-the-Counter Status?


Regardless of how split Americans are with regard to the abortion debate, we should all be able to agree on the need to prevent pregnancies. However, an obvious approach to pregnancy prevention is being sidelined by the lack of over-the-counter availability of hormonal contraceptives.

Regardless of how split Americans are with regard to the abortion debate, we should all be able to agree on the need to prevent pregnancies. However, an obvious approach to pregnancy prevention is being sidelined by the lack of over-the-counter availability of hormonal contraceptives.

Sadly, the US has one of the world’s highest of rates of unintended pregnancies, particularly among teenage girls.[1]  About half of all pregnancies are unintended, and in spite of Oklahoma and other states’ incremental policies to restrict abortion, 42 percent of those unintended pregnancies are voluntarily terminated.[2] While public policy discussions tend to focus on the hot-button issue of abortion, one approach that could substantially reduce the number of unplanned pregnancies is undermined by unnecessary roadblocks from the Federal government—as well as health care providers—and therefore has not been given a sufficient chance. Hormonal contraception, such as the birth-control pill (BCP), vaginal rings, and patches, should be available without a prescription.

Hormonal contraception meets the Federal Food & Drug Administration (FDA) standards for non-prescription status; consumers can easily identify contraindications, directions for use are uncomplicated, the benefits outweigh risks, and health providers are not necessarily required. Not only is hormonal contraception not available without a prescription, many clinicians force unnecessary medical examinations before allowing women access. In addition, the “conscience regulation” enacted by George W. Bush and not yet overturned by President Obama, allows health care providers to withhold prescriptions and even give patients inaccurate medical information, if they so choose.

Though we often hear of a possible association between BCPs and strokes or heart attacks, those risks are much lower than the risk of suffering liver damage from over-the-counter acetaminophen. Aspirin and ibuprofen have even more safety risks, such as ulcers, bleeding, high blood pressure, and kidney disease.[3]  Hormonal contraception has been proven safe—pregnancy is seven times more dangerous than pills, smoking is 50 times more dangerous than pills, driving is 12 times more dangerous than pills[4]—according to numerous respected medical organizations, including the World Health Organization, the American College of Obstetricians and Gynecologists, the Royal College of Obstetricians and Gynecologists, and the American Medical Association.

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In a 2000 article, Emery University’s Robert Hatcher, professor of Gynecology and Obstetrics, stated that the BCP’s history has shown it to be perfectly safe for use over-the-counter. Arie Yeshaya, M.D. of the Department of Obstetrics and Gynecology, confirmed that severe complications are rare (venous thrombosis occurs in 6 out of 10,000 women using oral contraception, as opposed to 3 out of 10,000 non-oral contraception users). Daniel Grossman, Senior Associate at Ibis Reproductive Health, cites a 2004 US national survey of women that reported 41 percent of women not using contraception said they would begin using the pill, patch, or vaginal ring if it were available without a prescription in a pharmacy. Another similar study found that travel away from home and running out of pill packs were common reasons women missed pills—a frequent cause of contraceptive failure.[5]

Why then, is the US still illogically holding birth control captive? In reality, the reason behind these pointless policies may not be health considerations, but rather moral objections on the part of the FDA, which contends that it is the pharmaceutical industry’s responsibility to seek approval for over-the-counter marketing of drugs. However, in 2000, the agency held a hearing to consider making BCPs available on a non-prescription basis and then ruled against it. It did the same with Plan B, also known as the morning after pill, prompting the 2005 resignation of Susan Wood, former Assistant Commissioner for Women’s Health. Wood was protesting the insertion of abortion-era politics into what should be a strictly health issue.

Not only are women in the United States required to make costly and time-consuming visits to a doctor’s office to get birth-control pill prescriptions, they are often required to undergo unnecessary and perhaps unwanted physical examinations and tests. The World Health Organization, Planned Parenthood Federation of America, and the American College of Obstetricians and Gynecologists,[6] and the American Medical Association, do not consider breast or pelvic examinations necessary for distribution of birth control pills. Incredibly, Sarah Jarvis, women’s health spokesperson of Royal College of General Practitioners in London, when arguing against allowing hormonal contraception available without a prescription, even stated that the pill is safe.[7]  

Why might women not want to meet with doctors? There are several possibilities. Given the state of our current economy, many women are already struggling financially and medical procedures compound expenses. For others, time is an issue. Some women find themselves in need of a prescription refill and unable to visit a clinic or get an appointment with a doctor in time. For some women, the intrusiveness of the exams and test is enough to prevent them from seeking them. Yet another reason, as exemplified by the recent change in pap smear recommendations, is that some women simply think the exams are unnecessary.  Until recently the standard recommendation, which many doctors and university clinics required, was an annual pap smear on record. This has recently been changed to every two years (every three for women over thirty).

Another concern asserted by Michael Cackovic, MD and Michael J. Paidas, MD[8] is that women will stop going for annual exams and pap tests if health centers don’t have a paternalistic policy of withholding contraception. According to this logic, no one should be allowed any medications unless they have all recommended physical exams. Over 55 and haven’t had a colonoscopy? Sorry, no flu shot for you. Misleading women is a form of coercion, not informed consent. Respect for the individual and their ability to make decisions is a basic principle of medical ethics. Not doing so is nothing short of provider bias and paternalism. Would women miss out on other preventive services, such as cervical smear tests or breast exams, if they were not required to visit a clinician? How many men actually go for their annual prostrate exam? Let’s allow women, like all mentally competent adults, to make their own decisions regarding their bodies. Shouldn’t patients, including women of child-bearing age, have the right to autonomy and bodily integrity? This logic could also be used to withhold long-lasting birth control such and IUD’s and sterilization. Not a good idea given the number of unintended pregnancies in the US.

Another hypothesis voiced by health professionals is that women might not understand how to take their contraception, however several international studies have found that over-the-counter provision of oral contraceptives by pharmacists is a safe, effective, and practical. Additionally, two US studies found that women were able to identify if oral contraceptives would not be a good choice for them.[9]

Already in Washington State, there is an initiative to de-medicalize hormonal contraception, thus making it readily available to women. Pharmacy Access Partnership, a center within the Pacific Institute for Women’s Health, is working with advocates, researchers, and providers to make hormonal contraception over-the-counter. Thus far, they’ve found it to be a practical idea and currently, one in five states has regulations that would permit pharmacists to provide pharmacy access to HC.

one stands on the abortion debate, most Americans would agree that it should not be a form of birth control and most wish to see it rarely used as a last resort. The prevention of pregnancy is a choice that women should be entitled to make for themselves. As consumers, we have the power to help to decrease unwanted pregnancies and access to hormonal contraception in pharmacies can be within our reach. Let’s encourage efforts to decrease abortion and increase women’s bodily autonomy by freeing contraception from the ties that bind it.

[1] Singh, S. and Darroch, J.E., “Adolescent pregnancy and childbearing: levels and trends in developed countries.” Family Planning Perspectives, 2000, 32(1): pg 14–23.

[2] Finer, L.B. and Henshaw, S.K., “Disparities in rates of unintended pregnancy in the United States.” Perspectives on Sexual and Reproductive Health, 2006, 38(2): pg 90–96.

[3] Childs, Dan. “FDA Scrutinizes Acetaminophen’s Liver Risk Concerns Over Unintentional Overdose Hazards May Change Drug’s Labeling,” June 29, 2009.

[4] “No prescription for the pill? FDA considers making the pill available over-the-counter.” June 29, 2009.

[5] BMJ 2008;337:a3044

[6] Leeman, L. “Medical barriers to effective contraception.” Obstet Gynecol Clin North Am. 2007; 34: pg 19–29.

[7] BMJ 2008;337:a3056

[8] Daniel Grossman, MD; Michael Cackovic, MD; and Michael J. Paidas, MD. “Viewpoints: Should oral contraceptives be sold over-the-counter?” Contemporary GYN/OB, September 1, 2008.

[9] BMJ 2008;337:a3044

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